[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"United Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100389996","study-on-the-efficacy-and-tolerance-of-a-new-anti-regurgitation-infant-formula-stellar-100389996",false,"NCT04358146","Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)","Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial","STELLAR","Inclusion Criteria:\n\n* ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,\n* exclusive or predominant formula feeding\n* whose parents signed informed consent\n\nExclusion Criteria:\n\n* preterm infants or birthweight \\\u003C2500g\n* Post enteritis lactose intolerance\n* Suspected or diagnosed cow's milk protein allergy requiring an eviction diet\n* Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)\n* Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject","ALL","2 Weeks","4 Months",{"count":21,"type":22},346,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.",[28],"Gastroesophageal Reflux in Children",[30],"Reflux","RECRUITING","2026-04-30",{"date":34,"type":35},"2026-05-04","ACTUAL",{"date":37,"type":35},"2023-03-17",{"date":39,"type":22},"2026-12-03",{"name":41,"class":42},"United Pharmaceuticals","INDUSTRY",12,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100553606","evolution-of-functional-gastrointestinal-disorders-in-infants-fed-with-a-new-infant-formula-100553606","NCT06488274","Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula","Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula","Inclusion Criteria:\n\n1. Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:\n\n   1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:\n2. Infants born at 35 weeks or more of gestational age\n3. Infants up to 4 months of age\n\nExclusion Criteria:\n\n1. Exclusively or partially breastfed infants (i.e. \\> 2 breast feeds per day) with maternal willingness to continue breastfeeding\n2. Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study\n3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)\n4. The willingness to take additional pre-, probiotics or thickening agents during the study\n5. Known allergy\u002Fintolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet\n6. Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient\n\n(non exhaustive list)",{"count":52,"type":22},139,[25],"This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.",[56],"Functional Gastrointestinal Disorders",[58,59,60,61,62,63,64],"Regurgitations","Colic","Constipation","Infant formula","GIGER scale","Nutrition","Infants","2025-01-02",{"date":67,"type":35},"2025-01-06",{"date":69,"type":35},"2024-10-21",{"date":71,"type":22},"2026-04",{"name":41,"class":42},4,""]